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Actonel significantly reduced osteoporotic fractures

10.02.2003


n high-risk postmenopausal women, at one year



Newly published data show that treatment with 5 mg Actonel® (risedronate sodium tablets) daily reduced the risk of spinal fracture in postmenopausal osteoporotic patients at higher risk of fracture because of age or low bone mineral density (BMD) at the hip. In these patients, fracture risk was reduced by 62 percent and 60 percent, respectively, at one year with Actonel compared with placebo. The analysis of combined data from two studies was published in the February issue of the Journal of Clinical Endocrinology and Metabolism, and also shows that the fracture reduction benefits of Actonel in patients at higher risk of fracture were similar to the benefits observed in the overall populations of patients with established osteoporosis.

"The ultimate goal of osteoporosis treatment is to prevent fractures. Providing rapid fracture prevention is critical to a high-risk patient group that, if left untreated, is likely to fracture soon," said Nelson Watts, MD, Director UC Bone Health Center, University of Cincinnati. "In this analysis, significant reductions in fracture risk were seen at one year with Actonel and underscore the importance of early identification and treatment of patients at high risk for fracture."


About Postmenopausal Osteoporosis

Postmenopausal women, who no longer naturally produce estrogen, are at high risk for developing osteoporosis -- a skeletal disorder characterized by reduced bone strength predisposing a person to an increased risk of fracture. According to the National Osteoporosis Foundation, 1.2 million women suffer osteoporotic fractures in the U.S. each year. In women with osteoporosis, independent risk factors for fracture include advanced age, pre-existing fractures, and low BMD. Studies show that among postmenopausal women with osteoporosis who experience a spinal fracture, one out of five will suffer their next spinal fracture within just one year, potentially leading to a fracture cascade.

While preventive measures, such as stopping smoking, maintaining a balanced diet supplemented with calcium and vitamin D, and engaging in weight-bearing exercise like walking, can reduce a woman’s chances of developing postmenopausal osteoporosis, in some women these measures may not be enough. Actonel has shown significant clinical benefit in both the prevention and treatment of osteoporosis.

About the Study

To determine the effect of Actonel on new spinal fractures in patients at high risk of fracture, data were pooled from two randomized, double-blind studies (VERT-MN and VERT-NA) in 2457 postmenopausal osteoporotic women treated with placebo or Actonel 5 mg daily. All women received 1000 mg per day calcium and up to 500 IU per day of vitamin D. A post hoc analysis evaluated fracture risk at one year in patients at high risk of fracture, defined in this analysis as age > 70 years or low hip BMD (T score < -2.5, based on the World Health Organization definition of osteoporosis).

In the subgroup of patients > 70 years of age, the incidence of new spinal fractures was 10.8 percent in the placebo group compared with 4.4 percent in the Actonel group, representing a fracture risk reduction in the Actonel-treated patients of 62 percent versus placebo (p < 0.001). Among patients with low hip BMD, the incidence of new spinal fractures at one year was 12.8 percent in the control group, compared with 5.6 percent in the Actonel group, reflecting a reduction in fracture risk in the Actonel patients of 60 percent versus control (p < 0.001). The fracture risk reductions in the high-risk subgroups with Actonel were similar to those seen in the overall population included in the analysis. In the overall population, the incidence of new spinal fractures at one year was 8.8 percent in the control group compared to 3.5 percent in the Actonel group – a 62 percent fracture risk reduction with Actonel (p <0.001).

These findings are also consistent with one-year spinal fracture reductions seen in other Actonel clinical trials.

About Actonel® (risedronate sodium tablets)

Actonel is co-developed and co-marketed by Procter & Gamble Pharmaceuticals and Aventis. Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention and treatment of osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment (≥ 7.5 mg/d prednisone or equivalent) for chronic diseases.

In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).

Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.

In clinical trials, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7 percent vs. Actonel 5 mg 29.9 percent), back pain (23.6 percent vs. 26.1 percent), and arthralgia (21.1 percent vs. 23.7 percent).

In a one-year clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily, the overall incidence of adverse events with the two dosing regimens was similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6 percent vs. Actonel 5 mg 19.0 percent), arthralgia (14.2 percent vs. 11.5 percent) and constipation (12.2 percent vs. 12.5 percent).


About The Alliance for Better Bone Health

The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe.

About Procter & Gamble

P&G is celebrating 165 years of providing trusted quality brands that make every day better for the world’s consumers. We market nearly 300 brands in more than 160 countries around the world. The P&G community consists of nearly 102,000 employees working in almost 80 countries worldwide. P&G Pharmaceuticals is part of P&G’s Health Care global business unit. P&G Pharmaceuticals is focusing in the areas of endocrinology, cardiovascular, and musculoskeletal diseases. Some of P&G’s leading prescription products include Actonel® (risedronate sodium tablets), Asacol® (mesalamine) and Macrobid® (nitrofurantoin monohydrate macrocrystals). Please visit www.pg.com for the latest news and in-depth information about P&G and its brands.

About Aventis

Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes, respiratory/allergy, anti-infectives as well as on human vaccines. In 2001, Aventis generated sales of € 17.7 billion ($15.8 billion), invested approx. € 3 billion ($2.7 billion) in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters is in Strasbourg, France. The company’s prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. Aventis Pharmaceuticals was recently named one of the top companies to work for by Working Mother magazine. For more information about Aventis in the U.S., please visit: www.aventis-us.com.

Copies of this release are available on the Procter & Gamble Pharmaceuticals Web site at http://www.pgpharma.com, the Aventis Pharmaceuticals U.S. Web site at http://www.aventispharmaus.com, or by calling 800/207-8049.

All statements, other than statements of historical fact included in this presentation, are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. In addition to the risks and uncertainties noted in this presentation, there are certain factors that could cause results for The Procter & Gamble Company to differ materially from those anticipated by some of the statements made. These include:(1) the successful execution of Organization 2005, including achievement of expected cost and tax savings and successful management of organizational and work process restructuring; (2) the ability to achieve business plan projections, including volume growth and pricing plans; (3) the ability to maintain key customer relationships including, without limitation, K-mart; (4) the achievement of growth in significant developing markets such as China, Korea, Mexico, the Southern Cone of Latin America and the countries of Central and Eastern Europe; (5) the successful integration of the Clairol business; (6) the continued political and/or economic uncertainty in Latin America and the Middle East; (7) any political and/or economic uncertainty due to terrorist activities; (8) the ability to successfully manage regulatory, tax and legal matters, including resolution of pending matters within current estimates; and (9) the ability to successfully manage current, interest rate and certain commodity cost exposures. If the Company’s assumptions and estimates are incorrect or do not come to fruition, or if the Company does not achieve all of these key factors, then the Company’s actual results may vary materially from the forward-looking statements made herein.

Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.

Mary Johnson | EurekAlert!
Further information:
http://www.pgpharma.com
http://www.aventispharmaus.com

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